Gallstones are a common problem in the United States and the most frequent cause of gallbladder inflammation. About 500,000 cholecystectomies are performed each year with an overall medical cost nearing approximately two billion dollars. Patients of all ages with cholecystitis have a mortality rate of 1.3% to 5%. For those over 65 years of age, the rate increases to 10%. When empyema of the gallbladder is present, the mortality rate is close to 29%. As the population ages, there will be more and more poor-risk patients with troublesome gallstones.
Removal of only gallstones, without a cholecystectomy, offers promise of reducing risk, but only solves the problem temporarily. Nearly 50% of the patients having a surgical cholecystostomy with the gallbladder left intact will have a recurrence of gallstones within three years or less, and 80% will develop stones within 15 years. As yet, there are no long-term follow-up studies for nonsurgical removal of gallstones by extracorporeal shockwave lithotripsy or by methyl-tertiary-butyl ether treatment. However, one study evaluating the recurrence of gallstones following another nonsurgical method of removal, bile-acid treatment, found the recurrence rate to be 24% at one year, rising to 58% at two years, 63% at three years, and 100% at five years. Other bile-acid treatment studies have indicated somewhat lower rates of recurrence, but 50% eventual recurrence seems to be generally accepted. Therefore, the need for preventing the recurrence of gallstones is significant. This is further heightened by eliminating the problem with a nonsurgical solution that will reduce the costs and the mortality rate associated with surgical methods.